Effects of Cranberry Extractive on the Lipid Profiles in Subjects With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00695526
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : June 17, 2008
Information provided by:
Taichung Veterans General Hospital

Brief Summary:
Cranberry, containing flavonoids, is effective on improvement of lipid profiles in non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid profiles in type 2 diabetic patients using oral antidiabetic drugs.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: cranberry Phase 3

Detailed Description:
Hypercholesterolemia is a notorious risk factor for cardiovascular disease. It had been reported cranberry consumption increased nearly 8% of circulating high-density lipoprotein (HDL) cholesterol levels in non-diabetic subjects. Although characteristics of diabetic dyslipidemia are low HDL and high triglyceride, the benefits of concentrated powder of cranberry juice on lipid profiles were not evident in type 2 diabetic subjects with diet control alone. To the best of our knowledge, the effect of cranberry on lipid profiles in type 2 diabetic subjects using oral anti-diabetic drugs have never been studied, especially total to HDL cholesterol ratio which is important in predicting cardiovascular diseases in Asian and/or diabetic population. Furthermore, cranberry has anti-oxidative effect which is associated with reduction of oxidized low-density lipoprotein (ox-LDL) cholesterol in non-diabetes. Therefore, we conducted a placebo-controlled, double-blind, randomized study to assess the effect of cranberry on lipid profiles in type 2 diabetes.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Cranberry on Lipid Profiles in Type 2 Diabetes
Study Start Date : May 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Dietary Supplement: cranberry
cranberry extractive in powder product (by Triarco Industries, Inc. NJ, USA) and encapsulated in dose of 500mg/capsule (by Topo digital tech co., Taiwan). By one capsule after each of three meals per day.

Primary Outcome Measures :
  1. the change of total to HDL cholesterol ratio [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride) [ Time Frame: 12 weeks ]
  2. the change of ox-LDL [ Time Frame: 12 weeks ]
  3. the change of fasting plasma glucose [ Time Frame: 12 weeks ]
  4. the change of HbA1c [ Time Frame: 12 weeks ]
  5. the change of CRP [ Time Frame: 12 weeks ]
  6. the change of UAE [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • type 2 diabetic subjects
  • age between 50 and 75 years

Exclusion Criteria:

  • glycosylated hemoglobin (HbA1c) less than 7% or more than 10%;
  • triglyceride more than 4.5 mmol/L;
  • current insulin treatment;
  • change of the medications for anti-diabetes, hypertension, hyperlipidemia and anti-platelet in recent four weeks;
  • abnormal renal function (serum creatinine > 177 μmol/L;
  • abnormal liver function test results (more than two-fold upper limit of normal range);
  • severe systemic disease such as immune disorder, cancer, acute or chronic inflammation disease;
  • smoking in recent 1 year;
  • alcoholism (more than two drinks daily);
  • using steroid or drugs with unknown components;
  • pregnancy or breast-feeding.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00695526

outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, Taiwan, 407
Sponsors and Collaborators
Taichung Veterans General Hospital
Principal Investigator: I Te Lee, MD Taichung Veterans General Hospital

Responsible Party: Department of Medical Education and Research, Taichung Veterans General Hospital Identifier: NCT00695526     History of Changes
Other Study ID Numbers: C06066
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by Taichung Veterans General Hospital:
total to HDL cholesterol ratio
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases